Current methods of assessing antibody mediated vaccine responses are used to measure rises in pre and post exposure antibody titers (i.e., neutralizing antibodies via ELISA). Though effective, the current methods necessitate a waiting period of approximately 30 days post antigen exposure before an assessment for efficacy can be made.
Similarly, while the presence of antibodies specific to an antigen can be used to determine antigenic exposure, a delay of 30 days post exposure creates a significant hurdle in the ability to provide a diagnosis to antigen exposure and delay treatment. In the event of an acute infectious disease, the disease will often have run its course before a diagnosis could be made using current methodology. Rapid diagnosis is even more essential in the event of a bioterrorism attack for containment and treatment of infected persons; situations where it is also essential to inform decisions to “shut down” major cities or ground all air travel which carry tremendous social, political and economic implications. Yet, current diagnostic methods are rooted in microbe identification and only work in a very restricted time window.
Moreover, plasma antibodies also suffer from many limitations as these tests are unable to distinguish newly proliferated antibodies from pre-existing circulating antibodies. Thus single samples may not reflect recent exposure and accurate diagnosis is delayed and complicated by the need of acute and convalescent samples. Further complicating matters is that current methodologies can require as much as 24 hours to perform, need specialized machinery not necessarily present in clinical laboratories, and need high trained technicians to perform. What is needed are new rapid highly specific and sensitive methods of antibody detection that can distinguish newly created antibodies from preexisting antibodies, and can reduce the level of skill needed to perform the task.